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Muscular and Functional Performance in FAIS Patients

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ClinicalTrials.gov Identifier: NCT03669471
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Lasse Ishøi, Hvidovre University Hospital

Brief Summary:

Following hip arthroscopy for femoroacetabular impingement syndrome (FAIS) decreased hip muscle strength for adduction, extension, flexion, and external rotation including impaired functional performance have been observed. However, no studies are lacking on more demanding muscular and functional parameters such as hip muscle rate of force development and reactive strength index. Information on such muscular properties following hip arthroscopy for FAIS may help guide future planning of post-operative rehabilitation strategies.

This is a cross-sectional study with an embedded prospective non-randomized study. The aim of the cross-sectional study is to investigate hip muscle function and functional performance in patients who have undergone hip arthroscopy for FAIS during the preceding 6-30 months.

The aim of the prospective non-randomized study is to investigate the effect of a 12-week structured and supervised physiotherapy-led intervention aiming at improving hip muscular function on self-reported hip and groin function including hip muscle function and functional performance.

Forty-five subjects from the Capital Region with an age of 18-40, who have undergone a hip arthroscopy for FAIS during the last 6-30 months, will be included in the cross-sectional study. Additionally, all included subjects will be offered to take part in the prospective non-randomized study consisting of 12 weeks of supervised and structured physiotherapy-led treatment.

The below measures will be obtained at baseline, and at 12-weeks follow-up if subjects are included in the prospective study. All testing, and supervised physiotherapy-led treatment, will be performed at Hvidovre Hospital:

  1. Hip muscle function
  2. Single leg jump performance
  3. Self-reported hip and groin function
  4. Evaluation of return to sport
  5. Evaluation of satisfaction regarding usual-care post-operative rehabilitation

Condition or disease Intervention/treatment
Femoroacetabular Impingement Other: Testing of performance

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Muscular and Functional Hop Test Performance in Femoroacetabular Impingement Syndrome Patients 6-30 Months Post Hip Arthroscopy - a Cross-sectional Study
Actual Study Start Date : September 13, 2018
Actual Primary Completion Date : September 10, 2019
Actual Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
FAIS group
Subjects who have had a hip arthroscopy for femoroacetabular impingement during the preceding 6-30 months
Other: Testing of performance

The cross-sectional evaluation will involve assessment of:

  1. Hip muscle function
  2. Single leg jump performance
  3. Self-reported hip and groin function
  4. Evaluation of return to sport
  5. Evaluation of satisfaction regarding usual-care post-operative rehabilitation

The exercise-based treatment will involve criteria-based physiotherapy aiming at improving muscle function around the hip and trunk.

Other Name: Exercise-based treatment




Primary Outcome Measures :
  1. Peak force [ Time Frame: Baseline (week 0) ]
    Peak isometric hip torque (Nm/kg) of abduction, adduction, extension, and flexion

  2. Rate of force development [ Time Frame: Baseline (week 0) ]
    0-100 ms and 0-200 ms rate of torque development (Nm/s/kg) of abduction, adduction, extension, and flexion

  3. Self-reported hip and groin function (subjects included in prospective study) [ Time Frame: Baseline (week 0) and follow-up (week 12) ]
    Obtained using the Copenhagen Hip and Groin Outcome Score (HAGOS); Scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems)


Secondary Outcome Measures :
  1. Single leg jump performance [ Time Frame: Baseline (week 0) ]
    Reactive strength index obtained during a single leg drop jump test

  2. Self-reported hip and groin function [ Time Frame: Baseline (week 0) ]
    Obtained using the Copenhagen Hip and Groin Outcome Score (HAGOS); Scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems)

  3. Return to sport [ Time Frame: Baseline (week 0) ]
    Obtained using a return to sport questionnaire; Scale: Preinjury sport at preinjury level vs. not preinjury sport at preinjury level.

  4. Satisfaction regarding usual-care post-operative rehabilitation [ Time Frame: Baseline (week 0) ]
    Obtained using a questionnaire; Scale: Satisfied with regular post-operative rehabilitation vs. not satisfied with post-operative rehabilitation.

  5. Change in Peak force (subjects included in prospective study) [ Time Frame: Baseline (week 0) and follow-up (week 12) ]
    Peak isometric hip torque (Nm/kg) of abduction, adduction, extension, and flexion

  6. Change in rate of force development (subjects included in prospective study) [ Time Frame: Baseline (week 0) and follow-up (week 12) ]
    0-100 ms and 0-200 ms rate of torque development (Nm/s/kg) of abduction, adduction, extension, and flexion

  7. Change in Single leg jump performance (subjects included in prospective study) [ Time Frame: Baseline (week 0) and follow-up (week 12) ]
    Reactive strength index obtained during a single leg drop jump test



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have undergone hip arthroscopy for femoroacetabular impingement syndrome during the preceding 6-30 months in the Greater Copehangen Area
Criteria

Inclusion Criteria:

  • Male/female at the age of 18-40 years at the time of surgery
  • Undergone hip arthroscopy for FAIS during the previous 6-30 months (surgical procedure: cam resection and labral surgery)
  • Pre-operative cam morphology specified as an alpha angle ≥55°

Exclusion Criteria:

  • Pre-surgery joint space width <3 mm
  • Any of the following surgical procedures at any time: extra articular surgery of the hip joint (except capsular closure), microfracture, periacetabular osteotomy, and surgery of the ligamentum teres; previous hip arthroscopy in the same hip joint; previous hip pathology such as Perthes' disease, slipped upper femoral epiphysis, hip dysplasia (Lateral Center Edge Angle <25°), and/or avascular necrosis; Any rheumatoid disease in the hip joint such as synovial chondromatosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669471


Locations
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Denmark
Testing and exercise-based intervention will be conducted at Hvidovre Hospital
Copenhagen, Denmark
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Principal Investigator: Lasse Ishøi Sports Orthopedic Research Center - Copenhagen (SORC-C), Ortopædkirurgisk Afdeling, Hvidovre Hospital
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Responsible Party: Lasse Ishøi, Principal Investigator, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03669471    
Other Study ID Numbers: FAIS2018
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes